Phase II Trial of Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax

University of Rochester1 site in 1 country48 target enrollmentMay 15, 2024

ConditionsStage 4 NSCLC Radiotherapy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Stage 4 NSCLC
Sponsor: University of Rochester
Enrollment: 48
Locations: 1
Primary Endpoint: Freedom from symptomatic progression of irradiated thoracic target(s)
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy.

Detailed Description

This will be a single-cohort Phase II single center, prospective trial. Patients with stage IV NSCLC are eligible. Patients may receive standard of care systemic therapy (chemotherapy and/or immunotherapy). Radiotherapy will be directed at high-risk disease (primary cancer, nodal metastases, and metastases) in the thorax. Treatment of other sites of extrathoracic metastases would be allowed as per standard of care. Standard chest radiation dosing and normal tissue exposures (based on published or ongoing studies) will be applied. There is no plan to escalate the chest radiation dose (i.e., no Phase I component) as palliative regimens for NSCLC have been routinely used for many decades.

Registry

clinicaltrials.gov

Start Date

May 15, 2024

End Date

February 1, 2029

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Michael Milano, MD,PhD

Michael Milano, Assistant Professor of Radiation Oncology at the University of Rochester School of Medicine and Dentistry

University of Rochester

Eligibility Criteria

Inclusion Criteria

•Pathologic diagnosis of Non-Small Cell Lung Cancer (NSCLC) without targetable/oncogene driven mutations (i.e., EGFR mutations, ALK-rearrangement, ROS1 rearrangement).
•T1-4(or Tx)N0-3M1a-c, Stage IV disease (using the 8th edition of the AJCC staging manual) or metastatic recurrence of primary Stage I-III NSCLC that had been treated with curative intent therapy, without prior thoracic radiotherapy.
•Thoracic lung and/or nodal lesion(s) amenable to palliative chest radiotherapy.
•All subjects are required to have one or more of the following high-risk features: a) a non-central primary lung lesion ≥5 cm in size (at least T3 by criteria); b) bulky (≥2 cm) parenchymal lung lesions and/or nodal lesions abutting (within 1 cm) any of the following: Proximal bronchial tree, Esophagus, Vertebra, Heart, brachial plexus or subclavian vessels (if brachial plexus not well visualized), Superior vena cava
•Prior systemic therapy is allowed. Subjects must be enrolled within 6 months of first cycle of systemic therapy for Stage IV disease.
•Systemic therapy following the thoracic radiotherapy (on protocol) is allowed.
•Prior palliative surgical treatment (including airway debridement) is allowed.
•Concurrent chemotherapy (chemotherapy delivered from ≤2 days of before through ≤2 days after radiotherapy) is NOT allowed.
•Concurrent immunotherapy therapy is allowed.
•Subjects may undergo (or may have undergone) standard extrathoracic radiotherapy off protocol, including (but not limited to): Palliation of symptomatic bone metastases, prophylactic palliation of high-risk bone metastases, cranial radiosurgery (with controlled intracranial metastases if performed prior to enrollment), Ablative or non-ablative definitive radiotherapy for oligometastases.

Exclusion Criteria

•Prior radiation therapy to the thoracic region.
•Active systemic lupus or Sjogren's disease.
•NSCLC (primary, nodal sites or metastases) causing severe symptoms requiring thoracic palliative radiotherapy for indications other than bone pain. These symptoms include superior vena cava syndrome, active and large volume (\>100 ml per day) hemoptysis, airway obstruction (stridor, post-obstructive pneumonia, progressive dyspnea not attributed to other causes), compression of the spinal cord or spinal nerve roots, vertebral compression fracture, brachial plexopathy (from compression).
•Baseline ECOG performance status of 3-
•For the purposes of eligibility, Karnofsky Performance Score (KPS) will be converted to ECOG/Zubrod performance score, per ECOG guidelines.
•Brain metastases not amenable to immunotherapy alone, resection or stereotactic radiosurgery (i.e., brain metastases requiring whole brain radiotherapy).
•Malignant pleural effusion attributable to grossly apparent pleural disease. Subjects with malignant pleural effusion amenable to therapeutic thoracenteses and without radiographic evidence of pleural disease (i.e., studding or masses) are potentially eligible.

Outcomes

Primary Outcomes

Freedom from symptomatic progression of irradiated thoracic target(s)

Time Frame: 6 month, 1 year, and 2 years

Kaplan-Meier freedom from symptomatic progression of irradiated thoracic target(s) at 6 months, 1 year, and 2 years.

Secondary Outcomes

Duration of time that patient is maintenance(6 month, 1 year, and 2 years)
OS (Kaplan-Meier) (Kaplan-Meier)(6 month, 1 year, and 2 years)
Freedom from local recurrence of irradiated thoracic target lesion(s)(6 month, 1 year, and 2 years)
PFS (freedom from local and distant progression; Kaplan-Meier)(6 month, 1 year, and 2 years)